Impact of Three Safety Interventions Targeting Off-Label Use of Immediate-Release Fentanyl on Prescription Trends: Interrupted Time Series Analysis.

Background: The Spanish health authorities are concerned by the off-label use of immediate-release formulations of fentanyl (IRF) in noncancer pain and cancer pain in patients with no chronic pain therapy. Aim: To evaluate the impact of different interventions to improve appropriateness of IRF prescription on off-label prescription. Patients and methods: We used interrupted time series (ITS) to estimate immediate and trend changes of IRF prescription for noncancer pain (NCP) and breakthrough cancer pain (BCP) in patients with and without chronic cancer pain therapy associated with two medication reviews (I1 and I2) and the issue of a safety warning letter (I3) with data from a Spanish region with 5 million inhabitants, from 2015 to 2018. Results: The use of IRF for NCP in the region Valencia was reduced from about 1,800 prescriptions per week to around 1,400. The first medication review was followed by an immediate level change of -192.66 prescriptions per week (p < 0.001) and a downward trend change of -6.75 prescriptions/week (p < 0.001), resulting in a post-intervention trend of -1.99 (p < 0.001). I2 was associated with a trend change of -23.07 (p < 0.001) prescriptions/week. After I3, the trend changed markedly to 27.23 additional prescriptions/week, for a final post-intervention trend of 2.17 (p < 0.001). Controlled-ITS provided comparable results. For potentially inappropriate BCP use, the second medication review was followed by a downward, immediate level change of -10.10 prescriptions/week (p = 0.011) and a trend change of 2.31 additional prescriptions/week (p < 0.001) and the issue of the safety warning (I3) was followed by a downward trend change of -2.09 prescriptions/week (p = 0.007). Conclusion: Despite IRF prescription for NCP decreased, the interventions showed modest and temporary effect on off-label prescription. Our results call for a review of the design and implementation of safety interventions addressing inappropriate opioid use.

The role of parental social class, education and unemployment on child cognitive development / El rol de la clase social, la educación y el desempleo parentales en el desarrollo cognitivo infantil

OBJECTIVE: Assessing the association between socioeconomic gradient and cognitive development among children of a Spanish birth cohort aged 5-6 years from a gender perspective. METHOD: Cognitive development was assessed on 525 children aged 5-6 years in the INMA-Valencia cohort, with the Global Cognitive Score (GCS) from McCarthy Scales of Children's Abilities. Information on social class, education level and employment was collected for both parents in addition to other sociodemographic factors, parental, family and child characteristics. The relationship between maternal and paternal socioeconomic gradient and cognitive development was assessed by linear regressions and comparing the variance explained by each indicator measured in the mother and father. RESULTS: Maternal socioeconomic gradient indicators explained more variance on GCS than paternal. Maternal education and paternal social class had an important individual effect that stayed after adjusting by other parental, child and family determinants. In the multivariable analysis, maternal education, age and intelligence, paternal social class and the child's age and sex were significantly associated with cognitive development. CONCLUSIONS: Diverse socioeconomic gradient factors have an important influence on cognitive development, maternal education being the strongest determinant. Policies should be implemented to mitigate the negative effects of this gradient on child development

OBJETIVO: Evaluar la asociación del gradiente socioeconómico y el desarrollo cognitivo en niños y niñas de una cohorte española a los 5-6 años de edad desde una perspectiva de género. MÉTODO: Se evaluó el desarrollo cognitivo en 525 niños/as de 5-6 años de la cohorte INMA-Valencia, mediante la Puntuación Global Cognitiva (PGC) de las Escalas McCarthy para niños y niñas. Se recogió información de ambos progenitores sobre clase social, nivel de estudios y empleo, además de otros factores sociodemográficos, características parentales, de la familia y del niño o la niña. La relación entre el gradiente socioeconómico materno y paterno y el desarrollo cognitivo se evaluó mediante modelos de regresión lineal y comparando la varianza explicada por cada uno de los indicadores medidos en la madre y en el padre. RESULTADOS: Los indicadores de gradiente socioeconómico de la madre explicaron más varianza del índice de PGC que los del padre. La educación materna y la clase social paterna tuvieron un importante efecto individual, que se mantuvo tras ajustar por otros determinantes de los progenitores, del niño o de la niña, y del entorno familiar. En el análisis multivariante, la educación, la edad y la inteligencia maternas, la clase social paterna, y la edad y el sexo del infante se asociaron significativamente con el desarrollo cognitivo. CONCLUSIONES: Distintos factores del gradiente socioeconómico tienen influencia en el desarrollo cognitivo, siendo la educación materna el determinante más fuerte. Deberían implementarse políticas para paliar los efectos negativos de este gradiente en el desarrollo infantil

The role of parental social class, education and unemployment on child cognitive development.

OBJECTIVE: Assessing the association between socioeconomic gradient and cognitive development among children of a Spanish birth cohort aged 5-6 years from a gender perspective. METHOD: Cognitive development was assessed on 525 children aged 5-6 years in the INMA-Valencia cohort, with the Global Cognitive Score (GCS) from McCarthy Scales of Children's Abilities. Information on social class, education level and employment was collected for both parents in addition to other sociodemographic factors, parental, family and child characteristics. The relationship between maternal and paternal socioeconomic gradient and cognitive development was assessed by linear regressions and comparing the variance explained by each indicator measured in the mother and father. RESULTS: Maternal socioeconomic gradient indicators explained more variance on GCS than paternal. Maternal education and paternal social class had an important individual effect that stayed after adjusting by other parental, child and family determinants. In the multivariable analysis, maternal education, age and intelligence, paternal social class and the child's age and sex were significantly associated with cognitive development. CONCLUSIONS: Diverse socioeconomic gradient factors have an important influence on cognitive development, maternal education being the strongest determinant. Policies should be implemented to mitigate the negative effects of this gradient on child development.